GUIDE, WIRE, ANGIOGRAPHIC

Wire, Guide, Catheter

LAKE REGION MFG., INC.

The following data is part of a premarket notification filed by Lake Region Mfg., Inc. with the FDA for Guide, Wire, Angiographic.

Pre-market Notification Details

Device IDK850827
510k NumberK850827
Device Name:GUIDE, WIRE, ANGIOGRAPHIC
ClassificationWire, Guide, Catheter
Applicant LAKE REGION MFG., INC. 340 LAKE HAZELTINE DR. Chaska,  MN  55318
ContactJim Klosterman
CorrespondentJim Klosterman
LAKE REGION MFG., INC. 340 LAKE HAZELTINE DR. Chaska,  MN  55318
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-02-25
Decision Date1985-06-26

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15414734054871 K850827 000
15414734054857 K850827 000
15414734054833 K850827 000
15414734054819 K850827 000
15414734054796 K850827 000

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